Randomized phase III study of intravenous (IV) paclitaxel and cisplatin vs. IV paclitaxel, intraperitoneal (IP) cisplatin and IP paclitaxel in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 172).

Trial ID # GOG-172
Phase III
Drug Class Chemotherapy
Drug Name Cisplatin, Paclitaxel
Alternate Drug Names CACP, cis-DDP, cis-platinum, CDDP, Platinol, Abiplatin , Blastolem , Briplatin , Cisplatyl , Citoplatino , Citosin , Lederplatin , Metaplatin , Neoplatin , Placis, Platamine , Platiblastin , Platiblastin-S , Platinex , Platiran, Platistin, Platosin, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL
Drugs in Trial Cisplatin, Paclitaxel
Eligible Participant

Newly diagnosed stage III ovarian cancer (optimally debulked)

Patients Enrolled

429

Therapy Setting

First-line

Study Design

Randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

CisPt+Pac (IV) vs CisPt+Pac (IP):

PFS: 18.3 vs 23.8 months, RR: 0.80 (0.64-1.00, p=0.05)
OS: 49.7 vs 65.6 months, RR: 0.75 (0.58-0.97, p=0.03)

Clinically Significant Adverse Events

CisPt+Pac (IV) vs CisPt+Pac (IP):
Grade 3-4 AE: leukopenia (64 vs 76%), GI events (24 vs 46%), neurologic events (9 vs 19%), infection (6 vs 16%), fatigue (4 vs 18%), metabolic events (7 vs 27%), decreased platelet counts (4 vs 12%), pain (1 vs 11%)

Conclusion

PFS and OS increased with IP treatment in optimally debulked stage III patients, but IP had more severe AEs

Reference

Armstrong DK et al. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. NEJM (2006) 354(1):34-43
https://www.ncbi.nlm.nih.gov/pubmed/16394300